Clinical trial

WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring

Name

HBS-101-CL-008

Description

The WAKIX (pitolisant) Pregnancy Registry is a US-based, prospective, observational cohort study designed to evaluate the association between pitolisant exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.

Trial arms

Trial start

2021-08-24

Estimated PCD

2030-06-30

Trial end

2030-06-30

Status

Recruiting

Treatment

Pitolisant

Exposure to at least one dose of pitolisant at any time during pregnancy

Arms:

Pitolisant-exposed participants with narcolepsy, Pitolisant-exposed participants without narcolepsy

Other names:

Wakix

Comparator Products

Exposure to at least one dose of a comparator product at any time during pregnancy

Arms:

Comparator-exposed participants with narcolepsy, Comparator-exposed participants without narcolepsy

Other names:

Modafinil/armodafinil, Sodium oxybate, Oxybate mixed salts, Solriamfetol, Methylphenidate, Amphetamines

Size

1329

Primary endpoint

Major congenital malformation

Enrollment through the infant's first year of life

Eligibility criteria

Inclusion Criteria: * Pregnant woman of any age * Consent to participate * Authorization for her HCP(s) to provide data to the registry * For participants with a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product, or, unexposed to pitolisant or comparator products at any time during pregnancy (i.e., any pregnant woman with a diagnosis of narcolepsy) * For participants without a diagnosis of narcolepsy: exposure to at least one dose of pitolisant or one dose of a comparator product at any time during pregnancy Exclusion Criterion: • Occurrence of pregnancy outcome prior to first contact with the Registry Coordination Center (RCC) (i.e., retrospectively enrolled)

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': True, 'targetDuration': '21 Months', 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 1329, 'type': 'ESTIMATED'}}

Updated at

2024-01-25

1 organization

2 products

2 indications

Product

Indication

Indication

Organization

Product